(This article is a summary of the issues discussed in
Duncan's 21 May 2008 presentation at the Generic Medicine
Industry Association conference in Sydney Australia.)
The Glivec battle in India
Novartis's ongoing stoush with the Madras High Court in
India created quite a stir on the world stage late last year.
It concerns the patentability of the Beta crystalline form of
Imatinib, the active pharmaceutical ingredient in the
blockbuster drug (Gleevec). (For those who are unaware, polymorphs are the various crystal forms
of a material.)
The case derives from substantial changes to the Indian
Patent Act made in 2005 and focuses on section 3(d) which bars
from patentability certain types of patents which have
traditionally been quite useful to innovator companies. The
'The following are not inventions within the
meaning of this Act,
'the mere discovery of a new form of a known substance
which does not result in the enhancement of the known
efficacy of that substance or the mere discovery of any new
property or new use for a known substance or of the mere use
of a known process, machine or apparatus unless such known
process results in a new product or employs at least one new
The case is currently mired in side issues about the
constitutionality of the section and the proper composition of
the Appeals Board which was to hear the appeal from the
original patent office decision. Please read our
August 2007 article for further background on the case.
One of the allegations that has been made by Novartis is
that India's section 3(d) does not comply with TRIPS. The
contrary argument (much propounded by Shamnad Basheer over at
SpicyIP) is that it does, as it is merely
an obviousness standard that member states are free to define
in a manner consistent with their national policy.
The controversy has become even more acute since a number of
other Asian countries have apparently foreshadowed that they
will enact provisions similar to India's 3(d). These
include the Philippines, Maldives, Pakistan, Sri Lanka,
Vietnam, Indonesia, Malaysia and Bangladesh.
So how are things looking in other jurisdictions?
A mixed bag...
United Kingdom criticises 'try on'
On 9 May 2008, the UK Court of Appeal handed down its decision in the Perindopril
(Coversyl) beta polymorph patent case. In essence, the patent
was held to be obvious in light of a prior patent owned by the
innovator (Servier) which disclosed...